BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL AUGMENT

    MDR report key: 9312946 · Received November 12, 2019

    Report

    Report Number
    1818910-2019-115757
    Event Type
    Injury
    Date Received
    November 12, 2019
    Report Date
    October 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿ROLE OF CAPSULAR REPAIR ON DISLOCATION IN REVISION TOTAL HIP ARTHROPLASTY¿ BY D.J. CHIVAS, MD., ET AL, PUBLISHED BY CLINICAL ORTHOPAEDIC RELATED RESEARCH (2006), NO. 453, PP. 147-152, WAS REVIEWED. THIS ARTICLE REVIEWS THE EFFICACY OF CLOSING THE JOINT CAPSULE DURING REVISION SURGERY AND WHETHER THIS REDUCES THE INCIDENCE OF POSTOPERATIVE HIGH JOINT DISLOCATIONS. THE AUTHORS DESCRIBE THE SURGICAL TECHNIQUE AND REVIEW THE POSTOPERATIVE RESULTS. THE AUTHORS REVIEWED 79 HIP REVISIONS. THE REVISED COMPONENTS WERE UNKNOWN. IMPLANTED PRODUCTS: THE ACETABULAR COMPONENTS AND ACETABULAR CAGES WERE COMPETITOR PRODUCTS. OF THE 56 REVISED FEMORAL STEMS, 36 WERE SOLUTION (DEPUY), 2 S-ROM (DEPUY), AND 6 CEMENTED ENDURANCE (DEPUY). THE SUTURE USED TO CLOSE THE CAPSULE WAS #1 VICRYL (ETHICON). THE REMAINING FEMORAL STEMS WERE COMPETITOR PRODUCTS. THE CEMENT MANUFACTURER WAS UNKNOWN. RESULTS FOR DEPUY PRODUCTS: THIS COMPLAINT WILL CAPTURE ALL RESULTS ASSOCIATED WITH DEPUY PRODUCTS. THOSE ADVERSE EVENTS ATTRIBUTED TO COMPETITOR PRODUCTS WILL NOT BE CAPTURED IN THIS COMPLAINT. THE AUTHORS DID NOT SPECIFY WHICH COMPONENT MANUFACTURER WAS ASSOCIATED WITH THE EVENTS LISTED. 39 HIPS WITH LEG LENGTH DISCREPANCY LESS THAN 2CM 1 NON UNION WITH SUPERIOR MIGRATION OF THE GREATER TROCHANTER- NO REVISION REQUIRED. 1 LOOSENING OF A CEMENTED FEMORAL STEM THAT MIGRATED. THIS STEM WAS REVISED. THERE WERE NO COMPLICATIONS OR EVENTS ATTRIBUTED TO THE ETHICON SUTURE. THERE WERE NO REVISIONS OF THE IMPLANTED FEMORAL STEMS IN THE TEXT OF THE ARTICLE. CAPTURED IN THIS COMPLAINT: DEPUY FEMORAL STEM AND AUGMENT FOR LIMB ASYMMETRY LESS THAN 2CM, STEM MIGRATION, IMPLANT LOOSENING, AND NONUNION CODED AS BONE INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107775 UNKNOWN HIP FEMORAL AUGMENT HIP FEMORAL AUGMENT JDI DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1